NCT04242758Unknown4 期
Exploring the Association Between Phthalates Exposure, Measured Through Their Urinary Metabolites, and Renal Function Impairment in Individuals With TYpe 2 Diabetes - SGLT2 Subprotocol
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Urinary Phthalates concentration
研究概览
简要总结
In this open clinical trial, 30 subjects with inadequately controlled T2D and eligible, as per good clinical practice, for therapy with SGLT-2 inhibitor, will be randomized to receive a SGLT-2 inhibitor vs other oral-antidiabetic drugs (OADs) therapy for 3 months. Measures will be performed at baseline, after 2 days, after one month and at the end of the study protocol, as per good clinical practice
详细描述
- Total concentrations of MEHP, MEOHP and MEHHP will be quantified, in the laboratories of the Institute of Clinical Physiology, National Research Council, Pisa, in a spot morning urine sample by ultra-HPLC coupled with electrospray ionization/quadrupole time-of-flight mass spectrometry (Agilent UHPLC 1290 infinity coupled to an Agilent 6540 MS-QTOF, Santa Clara, CA) using stable isotope labeled substrates, i.e. MEHP (ring-1,2-13C2, dicarboxyl-13C2), MEHHP, MEHHP 13C4, MEOHP and MEOHP 13C4 that will be purchased from Cambridge Isotope Laboratories (Tewksbury, MA).
- Urinary creatinine concentrations will be measured to adjust urinary concentrations of DEHP metabolite (Beckman Coulter AU400, Brea, CA), thus minimizing the influence of urine volume.
- Serum and urinary inflammatory markers and adipocytokines will be quantitatively determined using sandwich enzyme-linked immunosorbent assays kits according to the manufacturer's instructions. Optical density will be measured using a microplate reader.
- Serum and urinary markers of oxidative stress will be measured by gold standard techniques. In detail, MDA will be quantified by TBARS reactive substances measured by optical density; GSH-Px by a specific assay kit according to the manufacturer's instruction; SOD activity will be determined using a specific SOD kit; urinary 8-isoprostane concentration will be measured by a specific affinity sorbent. (Cayman Chemical, Ann Harbor, MI, USA) according to the manufacturer's instructions.
- To analyze mitochondrial DNA we will apply a triplex design previously reported to amplify mitochondria loci located within the MinorArc and MajorArc, respectively. To assess nuclear DNA, we will use RNase P Copy Number Reference.
- The phthalates-free diet will be self-administered by the individuals under intervention, following a set of instruction and rules provided by the physicians based on the current literature data.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals of both sex;
- •Age between 18 and 85 years;
- •T2D duration > 6 months
- •BMI ≤ 40 Kg/m2,
- •HbA1c > 48 mmol/mol
- •Eligible for SGLT-2i therapy
- •Exclusion criteria
- •age >85 years,
- •eGFR <60 ml/min/1.73 m2,
- •occurring acute complications
排除标准
- 未提供
研究组 & 干预措施
Dapaglifozin
Experimental
People undergoing SGLT2i (Dapaglifozin) therapy
干预措施: Dapagliflozin 10 MG (Drug)
Hydrochlorothiazide
Experimental
People undergoing thiazide (Hydrochlorothiazide) therapy
干预措施: Hydrochlorothiazide 12.5mg (Drug)
结局指标
主要结局
Urinary Phthalates concentration
时间窗: Changes between baseline and 3 month
Exposure to phthalates assessed through urinary excretion spot and 24-hours
次要结局
- Renal function(1 and 3 months)
- Glycated Haemoglobin(1 and 3 months)
- Albumin excretion(1 and 3 months)
- Macrovascular events(1 and 3 months)
- Fasting glucose(1 and 3 months)
研究者
Anna Solini
Associate Professor
University of Pisa
研究点 (1)
Loading locations...
相似试验
已完成
不适用
Mesalamine and Reproductive Health StudyColitis UlcerativeCrohn DiseaseNCT01331551Harvard School of Public Health (HSPH)130
已完成
不适用
The Relationship of Phthalate Exposure During Pregnancy and PreeclampsiaPhthalate ExposurePreeclampsiaEstrogenProgestinNCT04777929Second Affiliated Hospital of Wenzhou Medical University60
Unknown
不适用
The Effect of Periconceptional Phthalates Exposure on Couples' Reproductive HealthEnvironmental ExposureInfertilityNCT03679000Tongji Hospital2,122
Unknown
1 期
Open-label Study of TH-302 and Dexamethasone With or Without Bortezomib or Pomalidomide in Subjects With Relapsed/Refractory Multiple MyelomaMultiple MyelomaNCT01522872Threshold Pharmaceuticals98
Unknown
不适用
Impact of PTFE-d Barrier Intentionally Exposed to Bucal Environment in Guided Bone Regeneration to Ridge PreservationRidge PreservationNCT04329351Fernanda Vieira Ribeiro40